Our objective was to quantify the impact on the use of zolpidem of the obligation implemented in France in 2017 to use secure prescription pads to prescribe it. We conducted a cohort study within the ...French SNDS healthcare database. Patients aged over 18 years of age were considered for inclusion. The number of prevalent users and incident episodes of zolpidem use were compared before the change in law (July 1, 2016 to January 1, 2017) and after (July 1, 2017 to January 1, 2018). A prevalent user was a patient who has been reimbursed for zolpidem at least once. An incident episode of zolpidem use was defined by a first administration of zolpidem without any prior administration within the previous six months. Regarding prevalence of zolpidem users, we observed a decrease from 2.79% (CI95%:2.75-2.83) to 1.48% (1.44-1.51), with a number of patients who stopped taking it after the change in law being approximately 4.3 times higher than the number of patients who started. We observed a negative association between the post-law change period (OR = 0.52 (0.51-0.53)) and the probability of receiving zolpidem, adjusting for sex, aging, low income and chronic disease. We observed a decrease from 183 treatment episodes per 100,000 insured months on average to 79 episodes per 100,000 insured months, with an incidence rate ratio (IRR) equal to 0.43 (0.38-0.49). The use of secure prescription pads seems to have reduced the exposure of the French population to zolpidem.
Aims
To evaluate the risk of pleural disorders (PD) associated with 33 protein kinase (PK) inhibitors (PKIs) through a disproportionality analysis and to identify which PKs and pathways are involved ...in PKI‐induced PD.
Methods
To evaluate the risk of PD, reporting odds ratios (RORs) were calculated for 33 PKIs through data registered in the World Health Organization safety report database (VigiBase). We undertook a literature review to identify PKs that were possibly involved in PD caused by PKIs. Pearson correlation coefficients (r) between RORs and affinity data of 19 PKIs were calculated to identify the cellular target most likely to be involved in PKI‐induced PD.
Results
A total of 235 110 individual case safety reports were extracted from the database for 33 available PKIs. Among these reports, 5001 concerned PD (2.1%). Significant and positive disproportionality for PD was found for 29 of 33 PKI included in our study with top values for dasatinib ROR = 115.3; 95% confidence interval (CI): 110.1–120.8, bosutinib (ROR = 20.4; 95% CI: 15.8–26.4) and ponatinib (ROR = 12; 95% CI: 9.2–15.6). Correlation analyses between the product of dissociation constant and ROR highlighted possibly Lyn involvement in PD with PKI (r = 0.73, P = 0.0004).
Conclusions
Our study showed that 28 of the 33 tested PKIs were associated with PD. Besides, the study highlighted the role of Lyn in PD caused by PKIs through an immune‐mediated process.
Few studies have examined the consumption trajectories of inmates after entry to prison. The aim of this study was to assess the changes in the consumption of psychoactive substance between the ...period before detention and during incarceration and to characterize the profiles of prisoners with similar consumption trajectories during incarceration.
A multicenter, cross-sectional study was performed in all of the prisons from one region of France. All prisoners incarcerated during their 3rd months, over 18 years old, and with a sufficient level of French fluency to participate in the study were recruited over a period of 12 months. A total of 800 prisoners were recruited. All prisoners were interviewed face-to-face by a trained interviewer. A majority of prisoners had used at least one psychoactive substance in the weeks prior to incarceration. During incarceration, a substantial reduction in alcohol and illicit drug consumption was observed. The initiation of consumption and an increase in consumption were primarily related to medications. Five different profiles of consumption before incarceration were identified. These profiles all had a high probability of migrating to a similar profile during detention, characterized by less severe consumption of psychoactive substances.
Based on their consumption profile prior to incarceration, most prisoners would benefit from a specific medical evaluation as soon as possible following entry into detention. Prison could be an opportunity for reduced consumption and/or the initiation of treatment for the majority of prisoners, despite the pejorative development observed for a minority of prisoners during incarceration.
Sickle cell disease (SCD) induces chronic haemolytic anaemia and intermittent vaso-occlusion that results in tissue ischaemia causing acute, severe pain episodes that can lead to frequent ...hospitalizations. These consequences can have repercussions on family, social, school and/or professional life. Here, we present some of the results of the PHEDRE study (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease), which is the largest study of patients with SCD in France. This paper intends to describe characteristics of the French SCD population. We also aimed to assess the impact of the disease on the lives of patients using objective and subjective variables.
The PHEDRE study was a national multicentric observational study. Adults, adolescents and children with a confirmed SCD diagnosis were included in the study by their referring doctor. Then, they were interviewed by phone about their socioeconomic status, about the impact of the disease on their lives and about their analgesic and psychoactive drug use.
The study population consisted of 872 patients (28% were minors). Seventy-two percent of adults were active, and all minors were in school. Many patients presented criteria of severe SCD. Seventy-five percent were homozygous SS, 15% were double heterozygotes SC and 8% were heterozygotes Sβthal, 87% received specific treatment, 58% were hospitalized at least once for vaso-occlusive crisis in the past 12 months, and the number of analgesic drugs taken averaged 3.8. Seventy-five percent of patients reported academic or professional consequences related to their SCD, and 52% reported social consequences.
The impact of SCD on patients' lives can be significant, nevertheless their social integration seems to be maintained. We highlighted respect of recommendations regarding analgesic treatments and only a few patients used tobacco, alcohol or cannabis.
Clinical Trials, NCT02580565; https://clinicaltrials.gov/ Registered 16 October 2015.
Illicit substance use has constantly evolved over the years, particularly in the party scene. Monitoring these changes is essential to adapt harm reduction strategies. The OCTOPUS survey was ...implemented to enhance knowledge on drug use at music festivals. The objective of the work presented here was to describe drug use and to characterize profiles of substance use in music festival attendees.
OCTOPUS was a cross-sectional survey carried out during 13 various music festivals (dub, eclectic and electronic music) in the Loire-Atlantique department (France) from July 2017 to July 2018. Participants were festival attendees. Data were collected by trained research staff using a face-to-face structured interview. We analysed the use of illicit drugs in the last 12 months to describe the prevalence of use and to characterize the profile of substance use using a latent class analysis.
In total, 383 festival attendees were included. Of 314 (82%) participants who reported drug use, the most reported drugs were cannabis, ecstasy/MDMA and cocaine. We identified two profiles of drug use: (i) a "no/low polysubstance use" profile mainly characterized by the use of "classic" stimulants (ecstasy/MDMA, cocaine) and (ii) "moderate/extensive polysubstance use", with high probabilities of "classic" stimulants use and especially other drugs reported: speed, ketamine, new psychoactive substances (NPSs).
We observed frequent polysubstance use in festival attendees. Harm reduction should be targeted at the increased risk of toxicity linked to polysubstance use, and the reduction in harm caused by particular drugs (ketamine, NPS, speed) could be further strengthened.
Geophagia is a feeding behavior involving the regular intake of soil, including clay-like kaolin. Frequent in Africa, kaolin consumption is associated with heavy metal intoxication, iron and other ...micronutrient deficiencies, geohelminth infection and inactivation of concomitantly taken drugs. It is expected that this practice would be imported into an asylum country during the immigration process. To confirm this hypothesis, a single center, cross-sectional study was conducted at the University Hospital of Nantes, France, whose main objective was to assess whether the prevalence of kaolin consumers was high in a migrant population living in a large French metropolitan area (the city of Nantes). Each woman consulting for the first time at the Medical and Psychosocial Gynecology Obstetric Unit during the inclusion period ranging from January 1, 2017, to July 1, 2017, was asked for consent to be included in the study. The main outcome was the proportion of positive answers regarding consumption of kaolin within the last twelve months, with its 95% confidence interval (CI). A logistic regression was performed to identify drivers of consumption, and a clustering approach was conducted to identify profiles of consumers. A total of 284 women were included in the study, of whom 110 (38.7%) were pregnant. Our main finding was a 14.1% (95% CI: 10.5-18.6) prevalence of clay consumers. Second, the characteristic most strongly associated with consumption was Central or West Africa origin (adjusted Odds Ratio (aOR) = 52.7; 95% CI: 13.7-202.2). Finally, 60% of consumers showed signs of addictive-like phenomena, and three profiles were identified, depicting a continuum of patients in regard to their control over their kaolin consumption. Our results suggest that kaolin consumption is frequent in particular subpopulations of migrants. This warrants further study of the clinical consequences of kaolin consumption and its associated addictive-like symptoms.
Purpose
Benzodiazepines (BZDs) and related drugs (Z-drugs) are mainly taken chronically, and older people are much more likely to take them on a chronic basis despite recommendations. Withdrawal ...symptoms could be an obstacle to stopping BZD/Z-drug administration. The main objective of this study is to estimate the prevalence of withdrawal symptoms in patients aged 65 years and older who have experience a stop of BZD/Z-drug. The secondary objectives are to describe the withdrawal symptoms and identify factors associated.
Method
This ancillary study was based on a national observational study in patients with chronic BZD/Z-drug consumption. Patients who made at least one BZD/Z-drug stop experience were selected. Withdrawal symptoms are described, and a logistic regression was carried out to identify the variables most associated with withdrawal symptoms.
Results
In total, 697 patients were selected: 78% experienced at least one withdrawal symptom after a stop administering BZDs or Z-drugs; most of the withdrawal symptoms were psychological disorders.
Conclusion
Our study identifies a specific population experiencing withdrawal symptoms and who cannot stop administering BZD/Z-drug. We assume that withdrawal symptoms in patients with chronic use play an essential role in the nonstop use of BZD/Z-drugs.
Abstract
Aims
Despite recommendations to initiate clozapine after two unsuccessful trials of antipsychotics, clozapine is underprescribed and initiated too late. The aim of this study was to describe ...different antipsychotic treatment sequences in the 36 months before the initiation of clozapine and to characterize clusters of treatment trajectories.
Methods
Using the French National Health Insurance database, a historical cohort study of the population in an area in western France was performed. The data from all new users of clozapine with a diagnosis of schizophrenia or schizoaffective disorder in the period of 2017–2018 were evaluated. All outpatient reimbursements for antipsychotics during the 36 months before clozapine initiation were analysed. Successive reimbursements for identical treatments were grouped into treatment trials (TTs), and different trajectories were clustered using a state sequence analysis.
Results
The results showed 1191 TTs for 287 individuals. The mean number of TTs per individual was 3.2. Risperidone, aripiprazole and haloperidol were the main treatments delivered. The frequencies of antipsychotics used differed between monotherapies and combination therapies. A three-cluster typology was identified: one cluster (
n
= 133) of ‘less treated’ younger individuals with fewer TTs and shorter TT durations; a second cluster (
n
= 53) of ‘more treated’ individuals with higher numbers of TTs and combinations of antipsychotics; and a third cluster (
n
= 103) of ‘treatment-stable’ older individuals with longer TT durations.
Conclusions
The results indicate that the median number of TTs during the 36 months before clozapine prescription was higher than the two recommended. The different trajectories were associated with individual characteristics and treatment differences, suggesting that additional studies of clinical parameters are needed to understand barriers to clozapine prescription.
Background: To “limit the risk of abuse and misuse” and “encourage correct usage”, the French drug regulatory authority stated that—from April 2017—zolpidem prescription must be performed on a ...secured prescription pad. This national study aims to evaluate the perception of general practitioners (GPs) towards this new regulation and its link with prescription strategies. Methods: We conducted structured interviews of GPs. Data were collected about GPs’ perception of the measure and therapeutic strategies towards zolpidem. The primary outcome was the description of the GPs’ strategy of prescription, based on the perception towards the new regulation for zolpidem. Results: For 206 GPs, the new regulation was mainly perceived as helpful (61%) and as a difficulty (55%). Other perceptions were the awareness of the risks of zolpidem (18%), awareness of the risks of hypnotics (13%), and nothing changed (5%). Four clusters of GPs were identified. In the clusters with the perception as a difficulty (only or associated with helpful), the GPs who applied the strategy “no modification” for >50% of their patients were more frequently compared to awareness and helpful only clusters (60.8%; 42.9%; 20.4%; 26.7%) (p < 0.001). Conclusions: We highlighted an association between the perception of the new regulation of zolpidem prescription by GPs and a strategy of prescription.
Poppers are legal and largely used in France despite severe side effects, such as methaemoglobinaemia (MetHbia). Our work aimed to assess the prevalence of poppers consumers among patients with a ...MetHbia higher than or equal to 5% in French university hospitals and its evolution before and after the legalization of poppers in France. We conducted a national multicentre observational retrospective study. All patients for whom at least one MetHbia measurement was performed from 2012 to 2017 in university hospitals where the French addictovigilance network (FAN) is implanted were included. For each MetHbia measurement exceeding or equal to 5%, a return to the clinical file was made by the FAN to assess poppers consumption. We calculated the prevalence of MetHbia exceeding or equal to 5% and 25% and the prevalence of poppers consumption before and after the legalization. A total of 239 (0.14%) patients had a MetHbia level exceeding or equal to 5% with 25 (10.46%) cases of poppers consumption. Poppers consumption represented 68.4% (13 out of 19) of cases with MetHbia greater than or equal to 25%. Poppers consumption among patients with MetHbia exceeding or equal to 5% increased after the legalization from 4.76% to 11.67% (prevalence ratio PR = 2.45, 95% CI = 0.98–8.37, p-value = 0.190). The proportion of patients with a MetHbia level of 25% or more increased after the legalization from 4.76% to 8.63% (PR = 1.81, 95% CI = 0.68–6.82, p-value = 0.374). The use of poppers is very frequently reported by patients with MetHbia greater than or equal to 25%.
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